Reeves v. AcroMed Corp.

• Decision Date: 20 January 1997
• Docket Number: No. 96-30307,96-30307
• Citation: 103 F.3d 442
• Parties: , Prod.Liab.Rep. (CCH) P 14,836 Dorothy Marie REEVES, Plaintiff-Appellee-Cross-Appellant, Randy J. Ungar, Intervenor, v. ACROMED CORP. et al., Defendants-Appellants-Cross-Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

Page 442

103 F.3d 442

65 USLW 2500, Prod.Liab.Rep. (CCH) P 14,836

Dorothy Marie REEVES, Plaintiff-Appellee-Cross-Appellant Randy J. Ungar, Intervenor, v. ACROMED CORP. et al., Defendants-Appellants-Cross-Appellees.

No. 96-30307.

United States Court of Appeals Fifth Circuit.

Jan. 20, 1997.

Darryl J. Tschirn, La Jolla, CA, for Dorothy Marie Reeves.

Mark Herrmann, Richard Irving Werder, Jr., Elizabeth Ann Shaver, Jones, Day, Reavis & Pogue, Cleveland, OH, B. Frank Davis, Bernard, Cassisa and Elliott, Metairie, LA, for AcroMed Corp. and Arthur Steffee.

Arthur Sheridan Patron, Jr., Brian Barry Rippel, Henican, James & Cleveland, Metairie, LA, for St. Paul Fire and Marine Ins. Co. Donald R. Stone, Raymond B. Biagini, Larry R. Pilot, McKenna & Cuneo, Washington, DC, James M. Beck, Pepper, Hamilton & Scheetz, Philadelphia, PA, for Medical Device Mfrs. Ass'n, amicus curiae.

Appeal from the United States District Court for the Eastern District of Louisiana.

Before KING, JOLLY and DENNIS, Circuit Judges.

DENNIS, Circuit Judge:

This is the second appeal arising from a products liability action filed by the plaintiff-appellee, Dorothy Marie Reeves ("Reeves"), alleging that a metal bone implant manufactured and marketed by the defendant-appellant, AcroMed Corporation ("AcroMed") aggravated and compounded her back injuries. In the first appeal this court vacated the district court's judgment in favor of Reeves based on a jury verdict awarding her damages of $475,000 against AcroMed and remanded the case for retrial. Reeves v. AcroMed Corporation, 44 F.3d 300 (5th Cir.1995), cert. denied, 515 U.S. 1104, 115 S.Ct. 2251, 132 L.Ed.2d 258 (1995)("Reeves I"). After retrial, the district court rendered judgment in favor of Reeves against AcroMed and Dr. Arthur Steffee ("Steffee"), chairman of AcroMed and inventor of the metal bone implant, implementing a jury award to Reeves of $318,000 in damages. We affirm the judgment against AcroMed but reverse it insofar as it affects Steffee. Reeves' unreasonably dangerous per se claim is not preempted by the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act. 21 U.S.C. § 360k(a). Under the law of this case established in Reeves I we will not reexamine whether Reeves' unreasonably dangerous per se claim should have been presented to the jury. Steffee was not a manufacturer of the metal bone implant because he personally did not place the product on the market or introduce it into the stream of commerce.

BACKGROUND

In December 1985, the plaintiff-appellee, Dorothy Marie Reeves, seriously injured her back. She was diagnosed as having spinal stenosis. To alleviate this condition, her neurosurgeon attempted a complicated procedure that entailed fusing grafts of bone from Reeves' hip into her spine at four different levels of her vertebrae. As part of this surgery, metal bone plates and screws manufactured by the appellant, AcroMed, were implanted into Reeves' back to secure the fusion. Reeves' condition initially improved after surgery. However, six months after the surgery, Reeves began to suffer from back pain that had not existed prior to the surgery. Reeves continued to suffer from this pain and in December 1991, filed suit against AcroMed alleging that AcroMed's products implanted in her back were defective. Reeves based her cause of action on several theories of recovery including, failure to warn, defective design, defective manufacturing, and the "unreasonably dangerous per se" category of products liability. Reeves I, at 308; See Halphen v. Johns-Manville Sales Corp., 484 So.2d 110, 113-115 (La.1986). The jury returned a verdict in favor of Reeves, but did not specify upon which legal theory the verdict was based.

In Reeves I, this court held that the failure to warn theory was preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., and that Reeves failed to produce sufficient evidence to recover on her defective design and manufacturing theories. Accordingly, we vacated the judgment of the district court and remanded for retrial of Reeves' action predicated solely on the unreasonably dangerous per se theory. However, in Reeves I we found that Reeves presented sufficient evidence to have her unreasonably dangerous per se claim submitted to the jury, including the questions of whether the medical device was an unreasonably dangerous per se product and, if so, whether this product condition caused the exacerbation of Reeves' back injury. Id. at 308.

After trial on remand, the jury awarded Reeves $318,000 finding that AcroMed's medical device was unreasonably dangerous per se and this product condition caused the aggravation and compounding of Reeves' back injuries. On remand Reeves also brought a cause of action based on the unreasonably dangerous per se theory of recovery against Dr. Arthur Steffee, the inventor of the metal bone plates and screws implanted in Reeves' back and the chairman of the board of AcroMed. ¹ Before the commencement of Reeves' jury trial, the parties stipulated that if the jury returned a verdict in favor of Reeves, the judge would rule on Steffee's liability. After the jury rendered a verdict in Reeves' favor, the trial judge determined that Dr. Steffee was personally liable. We conclude that Reeves' unreasonably dangerous per se claim is not preempted, the law of the case doctrine mandates that we not reconsider the sufficiency of the evidence and causation issues with respect to Reeves' unreasonably dangerous per se claim against AcroMed, and the jury acted reasonably in awarding Reeves $318,000. However, we conclude that the district court erred in part by holding Steffee liable.

STANDARD OF REVIEW

We employ a three-tiered standard of review in this case. A court's findings of fact are reviewed for clear error and conclusions of law are reviewed de novo. Peaches Entertainment v. Entertainment Repertoire, 62 F.3d 690, 693 (5th Cir.1995). In reviewing a jury's findings of fact, we apply the standard set out in Boeing Co. v. Shipman 411 F.2d 365 (5th Cir.1969): "[A] jury verdict will not be overturned unless the facts and inferences point so strongly and overwhelmingly in favor of one party that the court believes that reasonable [jurors] could not arrive at a contrary verdict."

DISCUSSION

I. Reeves' Claim Against AcroMed

AcroMed first asserts that Reeves' state law unreasonably dangerous per se claim is preempted by the Medical Device Amendments of 1976 (MDA or Act) to the Food, Drug, and Cosmetic Act. 90 Stat. 539. 21 U.S.C. § 301, et. seq. In light of the Supreme Court's decision in Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), this argument is not persuasive.

Congress enacted the MDA to give the FDA authority to regulate medical devices. Lohr, 518 U.S. at ----, 116 S.Ct. at 2246. In Lohr, the Supreme Court explained the critical provisions of the MDA as background for its preemption analysis.

Medical devices are divided into three classes. Class III devices present potential unreasonable risks and are subject to the most intensive regulation. Id. The metal bone plates and screws implanted in Reeves' back are Class III devices. In order for a new Class III device to be marketed, the manufacturer of the device must provide the FDA with a reasonable assurance that the device is both safe and effective. Id. (citing 21 U.S.C. § 360e(d)(2)). This process, known as the "premarket approval" (PMA) process, is quite rigorous in that the FDA spends an average of 1200 hours on each submission. Id. at ---- - ----, 116 S.Ct. at 2246-47.

There are two exceptions to the PMA requirement. First, the statute grandfathers in all pre-1976 devices and allows those devices to remain on the market until the FDA initiates and completes a PMA. Id. at ----, 116 S.Ct. at 2247 (citing 21 U.S.C. § 360e(b)(1)(A)). Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure rapid introduction of improvements, the Act also permits devices that are "substantially equivalent" to preexisting devices to be marketed without the rigorous PMA review. Id. (citing 21 U.S.C. § 360e(b)(1)(B)).

However, all "substantially equivalent" devices are subject to the requirements of 21 U.S.C. § 360(k). That section imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a "premarket notification" to the FDA. This process is also known as the " § 510(k) notification or process," after the number of the section in the original act. We will use it hereinafter to avoid confusion between 21 U.S.C. § 360(k)(§ 510(k) notification or process) and 21 U.S.C. § 360k(a)(preemption provision). If the FDA concludes on the basis of the § 510(k) notification that the device is "substantially equivalent" to a pre-existing device, it can be marketed until the FDA initiates the PMA process for the underlying pre-1976 device to which the new device is "substantially equivalent." Id. In contrast to the rigorous PMA process, the § 510(k) process averages only 20 hours instead of 1200. Id.

The preemption provision of the MDA, 21 U.S.C. § 360k(a), reads as follows:

§ 360k. State and local requirements respecting devices

(a) General rule

Except as provided in subsection (b) of this section, no State may establish or continue in effect with respect to a device intended for human use any requirement--

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.

In Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996), petitioner Medtronic Inc.'s pacemaker was a Class III device found substantially equivalent under the § 510(k) process. Cr...